GENERIC NAME OF THE MEDICINAL PRODUCT:

a) Human Normal Albumin BP 5%
b) Human Normal Albumin BP 20%
c) Human Normal Albumin BP 25%

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Human Normal Albumin BP 5%
Each vial contains:
Total protein……………………50 g/Lit
Sodium Caprylate…………….1.66 g/Lit
Na+…. Not more than 160 mmol/Lit
K+...….Not more than 2 mmol/Lit
Aluminium……………………… ≤ 200 μg/Lit

b) Human Normal Albumin BP 20%
Each vial contains:
Total protein……………………200 g/Lit
Sodium Caprylate…………….6.65 g/Lit
Na+…. Not more than 160 mmol/Lit
K+...….Not more than 2 mmol/Lit
Aluminium……………………… ≤ 200 μg/Lit

c) Human Normal Albumin BP 25%
Each vial contains:
Total protein……………………250 g/Lit
Sodium Caprylate…………….8.3 g/Lit
Na+…. Not more than 160 mmol/Lit
K+...….Not more than 2 mmol/Lit
Aluminium……………………… ≤ 200 μg/Lit

THERAPEUTIC INDICATIONS:

HUMAN ALBUMIN is used to treat blood volume loss. It works by replacing the body fluids lost due to excessive trauma, bleeding, surgery, or kidney dialysis. Thus, it is helpful in treating low blood albumin levels.

CAUTION & WARNING:

Caution: It is dangerous to take this preparation except under medical supervision.
Warning: To be sold by retail on the prescription of the Registered Medical pharmacist only.
Active substance: human albumin
Source: Human plasma
Non-reactive for HBsAg, HCV, HIV antibodies and negative for HBV DNA, HIV RNA and HCV RNA by PCR.
Contains no preservatives.
Do not use if the solution is cloudy or turbid or if deposits have formed or if any particulate matters observed.
Contents must not be used more than four hours after the container has been penetrated and any remaining portion must be discarded.
Irrespective of blood groups, can be transferred to all recipients.
For Indication, caution, Dosage & Method of Administration please refer accompanying package insert.
Keep out of reach and sight of children.

STORAGE & DOSAGE:

Storage: Store the container between 2°C to 25°C. Do not freeze. Protect from light.
Note: shelf life of 36 months when stored at room temperature (up to +25°C)
Dosage: As directed by the physician.
For Oral use. Read the package insert before use.

Human Normal Albumin BP 20% (Aizen Life) Technical Specification:

Product Name:Human Normal Albumin BP 20%
Brand Name:Aizen Life
Strength:5% (5gm), 20% (20gm), 25% (25gm)
Dosage Form:Liquid Injection
Packing:100ml
Route of Administration:For I.V. use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Volume Expanders
Indication: HUMAN ALBUMIN is used to treat blood volume loss. It works by replacing the body fluids lost due to excessive trauma, bleeding, surgery, or kidney dialysis. Thus, it is helpful in treating low blood albumin levels.
Storage:Store the container between 2°C to 25°C. Do not freeze. Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Human Normal Albumin BP 20%

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Human Normal Albumin BP 20%
    Each vial contains:
    Total protein……………………200 g/Lit
    Sodium Caprylate…………….6.65 g/Lit
    Na+…. Not more than 160 mmol/Lit
    K+…….Not more than 2 mmol/Lit
    Aluminium……………………… ≤ 200 μg/Lit

THERAPEUTIC INDICATIONS:

HUMAN ALBUMIN is used to treat blood volume loss. It works by replacing the body fluids lost due to excessive trauma, bleeding, surgery, or kidney dialysis. Thus, it is helpful in treating low blood albumin levels.

CAUTION & WARNING:

Caution: It is dangerous to take this preparation except under medical supervision.

Warning: To be sold by retail on the prescription of the Registered Medical pharmacist only.

Active substance: human albumin

Source: Human plasma

Non-reactive for HBsAg, HCV, HIV antibodies and negative for HBV DNA, HIV RNA and HCV RNA by PCR.

Contains no preservatives.

Do not use if the solution is cloudy or turbid or if deposits have formed or if any particulate matters observed.

Contents must not be used more than four hours after the container has been penetrated and any remaining portion must be discarded.

Irrespective of blood groups, can be transferred to all recipients.

For Indication, caution, Dosage & Method of Administration please refer accompanying package insert.

Keep out of reach and sight of children.

STORAGE & DOSAGE:

Storage: Store the container between 2°C to 25°C. Do not freeze. Protect from light.

Note: shelf life of 36 months when stored at room temperature (up to +25°C)

Dosage: As directed by the physician.

For Oral use. Read the package insert before use.